Archives: Agenda
Morning refreshments and networking
From GDP Compliance to Global Standardisation: Building More Resilient Clinical Trial Cold Chains
- Overview of ISO/TC315 and its relevance to pharmaceutical and clinical trial supply chains
- Bridging the gap between current GMP/GDP expectations and future global standards
- How standardised cold chain frameworks can reduce operational variability
Data Privacy in Clinical Trials: The Sponsor’s survival guide
| · Why data privacy has become a critical success factor for clinical trials, and what is at stake for sponsors (delays, fines, data that cannot be used)
· The key requirements to know when running a trial in the EU, the US, Korea and China: roles, consent, DPO and local representative, data transfers. · Practical steps for sponsors to build privacy compliance into their trials from the start. |
Reserved for Phoenix Pharma
CASE STUDY: AriBio’s AR1001: Korea’s First Global Blockbuster Candidate for Alzheimer’s
- AR1001 is a first-in-class, oral, disease-modifying therapy poised to reshape Alzheimer’s treatment after two decades of limited progress
- We’ll cover the scientific breakthroughs and strategic lessons behind its development
- We’ll highlight AriBio’s focus on delivering the right therapy to the right patients, while meeting FDA and EMA regulatory standards
Selecting and Managing the Right CRO: A Strategic Guide for Korean Biotech
- Determining when and how to engage a CRO across the clinical development lifecycle
- Selecting a fit-for-purpose CRO based on program needs, risks and sponsor capabilities
- Small/mid-sized CRO versus large global CRO: choosing the right operating model
- Establishing effective governance and risk-proportionate sponsor oversight
Reserved for Novotech
PANEL DISCUSSION: Strengthening Collaboration Between Clinical Trial Supply and Clinical Operations
- Ascertaining how clinical supply can get a seat at the table with clinical operations to streamline capabilities
- Discovering how teams can collaborate and how technology can enable this
- Sourcing raw materials in order to produce products
- Overcoming logistical challenges within supply chain